Equipment qualification in pharmaceutical engineering – passing the test of time


Pharma industry is humungous, the most critical and by far the most significant, which the world today certainly cannot do without. Even as it has seen unprecedented evolution over the past few decades, it has faced its share of challenges.

These challenges often involve mishaps and incidents leading to widespread and severe effects. In the past, a few very common incidents occurred due to medicine contamination. They arose as a result of the intrusion of harmful pathogens and toxins in pharmaceutical drugs. Upon probing and investigations, it was found that in one of the cases, pharma laboratories were operating after the expiry date. In other cases, there were similar inexplicable and unpardonable reasons, viz. accidental lapse in manufacturing or not undergoing the requisite safety tests for the proposed new drugs.

These accidents make it all the more imperative that principles, practices and equipment qualifications are proactively ticked off before being given the go-ahead.

Even as we are in the business of setting up projects through putting up equipment and systems for unique pharma requirements, our project does not reach its finishing line until our clients, and we are given the reassurance that all equipment is duly qualified and comply with the prescribed principles and practices. 

In this blog, we share with you the important steps involved before the functioning of the equipment can be enabled.

Given below are a series of the tests that we follow to ensure reliable performance from each piece of equipment:

  1. User Requirement Specification (URS)
  2. Design Qualification (DQ)
  3. Factory Acceptance Test (FAT) at manufacturer’s site
  4. Site Acceptance Test (SAT) at the user site
  5. Installation Qualification (IQ)
  6. Operation Qualification (OQ)
  7. Performance Qualification (PQ)

User Requirement Specification (URS)

This is a formal document built at a preliminary stage that outlines general requirements and functional specifications along with organisational expectations from the equipment. A well-documented URS helps the supplier fully understand the client’s needs and enables clear-cut and concise written communication between both parties. URS also helps in the further stages of validation of installation qualification (IQ) and operational qualification (OQ) and, eventually, in building better quality products to suit the client’s needs and meet the intended purpose. Additionally, any possible disputes or conflicts of interest arising due to the absence of URS can be avoided with both parties on the same page. The URS must include the Objectives, Technical specifications, Design Data, Documentation, Installation and commissioning, Delivery, Training, Commercial Terms and Approvals.

Design Qualification (DQ)

Once the User Requirement Specification is finalised, the design qualification is prepared as a primary documented verification to ensure that the proposed equipment design meets the specifications and functionality and the supplier fulfils regulatory requirements needs. DQ takes place before the construction of the equipment to arrive at a decision on the equipment at the planning phase. Any deviation arising out of equipment details is identified, and risks are assessed, documented and submitted to the manufacturer. Thus, DQ can broadly be under the following three steps:

  • Ensuring the supply fulfils the technical and financial terms specified in the Purchase Order.
  • Verifying the specifications, reporting deviations, and submitting the same to the manufacturer.
  • Creating the summary of the result.

Factory Acceptance Test (FAT)

The factory acceptance test (FAT) is a functional test performed at the manufacturing site upon completion of the manufacturing process. The test is carried out to comprehensively verify the actual specification and functionality of the equipment against what is indicated in the datasheet, specification and purchase order. Thus, FAT largely involves inspecting the equipment’s quality and integrity along with reviewing its capability to run effectively in future operating environments. All possible failures are also looked into in advance while ensuring modifications, adjustments or replacements, as required.

Such rectifications facilitate control over the project while the system is still in possession of the manufacturer, i.e. before the equipment arrives at the customer’s site.

Written below are a few points that are borne in mind while conducting FAT-

  • Having a detailed test plan – It is quite beneficial to have detailed criteria specifying responsibilities, accountabilities, and deliverables. This preparation further helps measure the performance and leaves the provision for discovering failures, issues or inefficiencies.
  • Dry run testing – FAT undergoes an empty dry run or on substitute products. However, in exceptional cases, actual products may also be used for specific applications.
  • Operators Involvement – Equipment is run by operators who must be equipped with the technical skills and know-how to carry out the tasks. Involving and training them is fundamental to ensuring that the equipment doesn’t just function the right way but is also in the right hands.
  • Leaving room for failures – It is essential to have the potential failures written down. Then, in the event of any unexpected consequences, a backup plan must be kept ready to eliminate the scope of the equipment coming to a standstill.  
  • Having a detailed eye for problems –After thoroughly testing the equipment, problematic areas where the operator encounters difficulty must be identified and carefully checked. Questions like how the problems are to be rectified should be answered. The system must address what is missing to arrive at the right answers. 

Site Acceptance Test (SAT)

Site Acceptance Test work on the same principle as that of FAT, for they both pertain to verifying the functionality of the equipment. However, the difference lies in the location where the test is undertaken. SAT, as the name suggests, is conducted on-site. The tests reveal if the specifications of the equipment received by the manufacturer are met. The test involves a visual inspection of the components and the functionality of the utilities, and the compliance for overall safety and other parameters for overall usability. This is also the time to check the ability of the operator to handle the equipment and note down any further issues to be rectified. Finally, SAT gives both parties the final confirmation for performance. The tests primarily involve the under-mentioned steps:

  • Developing a plan outlining the goals, objectives, and approach of the SAT.
  • Execution of the test cases by the SAT team.
  • Generation of reports and documentation of the results.
  • Review of report and validation of results.

Installation Qualification (IQ)

Installation Qualification helps one ascertain all aspects relating to the equipment. This documented verification involves thorough checking of the specifications, design, and material used along with proper delivery, installation and configuration as per the written, approved standards. The installation is undertaken by training personnel who ensure that there has been a complete delivery of the equipment or the components.

The tests include the checking of the following:

  • Compliance with all specifications and review of design features to ensure completeness and exactness with the equipment
  • Examining and reporting components for damages. 
  • Gathering all manuals, drawings and certifications 
  • Establishing equipment maintenance, calibration schedules and procedures.

Re-qualification – There is a scope of re-qualification where any lapse or deviation that may further impact the quality of the equipment is noted, and a corrective action report is prepared. 

Operation Qualification (OQ)

After reviewing and approving the IQ execution result, the OQ execution process is carried out to ensure that the intended tasks can be performed. The process involves the following testing:

  • Testing of the instruments
  • Identifying parts that show any potentiality of malfunctioning. 
  • Checking the key parameters and functions and their compliance with the operating specifications.
  • Thorough check of the specification laid down during OQ by the site representative 
  • Reporting changes (if any) made to the system/equipment during OQ.
  • Preparation and approval of the Standard Operating Procedure (SOP) for operating & maintaining the equipment, instruments & system.

Re-qualification is required in the event of a change of location or the moving of equipment due to the change in location. Also, modifications made or a newly added component need to be qualified.

Performance Qualification (PQ)

After a successful SAT and an approved IQ and OQ, PQ is executed to determine the system’s performance, as defined in the protocol. The capability to operate under a specific environment is ascertained. The performance is tested to evaluate the real product’s performance under the equipment’s real process parameters. The user prepares a Standard Operation Procedure (SOP) during the PQ. The test reassures that the system/equipment can produce products with the specified quality and functionality, even in extreme cases.

This test can be called one affixing stamp on the reliability of the equipment. Similar to IQ and OQ, a room is kept for requalification in case new equipment is added. These modifications can have a bearing on the product performance and malfunctioning, if any, found after PQ is executed.

The validation tests are a part of Fabtech’s fundamental processes and protocols that comply with GMP requirements, user requirements specification and contractual specifications. Our steadfast testing ensures that each paperwork is given an unchallenged stamp of approval. As a result, we diligently endeavour to have our equipment work perfectly and meet its intended purpose at the customers’ plant and beyond.

We would love to connect with you for reliable and accurate equipment for your pharmaceutical needs.